A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation

Psoriasis Clinical Trial

Official title:

A Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study To Evaluate the Bioavailability of BMS-986165 Tablet Formulation Relative To BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal And Increased Gastric pH on the Bioavailability of BMS-986165 Tablet Formulation in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254784
• Other study ID #: IM011-031
• Status: Completed
• Phase: Phase 1
• Start date: September 13, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: February 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165 tablet formulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 15, 2017
• Est. primary completion date: November 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients must be willing and able to complete all study-specific procedures and visits

• Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations

• Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening

• Normal renal function at screening

Exclusion Criteria:

• Women of childbearing potential not using an effective contraceptive method or are breastfeeding

• Any significant acute or chronic medical illness

• History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months

• History of headaches related to caffeine withdrawal, including energy drinks

• History of syncope, orthostatic instability, or recurrent dizziness

• Active TB requiring treatment or documented latent TB within the previous 3 years

Other protocol defined inclusion/exclusion criteria could apply.

Related Conditions & MeSH terms

• Arthritic Psoriasis
• Arthritis, Psoriatic
• Inflammatory Bowel Diseases
• Lupus Erythematosus, Systemic
• Psoriasis
• Systemic Lupus Erythematosus

Intervention

Drug:
• BMS-986165 Capsule
Oral capsule
• BMS-986165 Tablet
Oral tablet

Locations

Country	Name	City	State
United States	PRA Health Sciences	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time		5 days
Primary	AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time		5 days
Primary	Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration [AUC(0-T)] derived from plasma concentration versus time		5 days
Primary	Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time		5 days
Secondary	Adverse events measured by incidence		26 days
Secondary	Serious adverse events measured by incidence		Approximately 55 days

External Links

•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry Form